推进真实世界研究的透明化

真实世界研究近几年在临床需求及相关政策的引导下快速发展,成为医药行业广泛关注的焦点。目前,对真实世界研究的证据强度、偏倚控制及研究价值等关键内容还缺乏深入的探讨。临床研究透明化是实现研究规范性、结果真实性和结论可靠性的重要保障。本文介绍提高真实世界研究透明化的必要性,从真实世界研究方案预注册、统计分析计划的发布、数据清洗方案的制定、结果报告规范和数据共享等方面阐述促进真实世界研究透明化的措施,以期更好控制混杂和偏倚,产出可用于临床相关决策的高质量证据,减少研究浪费。

Promote Transparency in Real-World Study

Real-world study(RWS)has been developing fast in recent years under the guidance of clinical requirement and relevant policies, and has become a hot topic in the field of medical research.At present, the key contents of RWS, such as evidence level, bias control and value etc., are still lack of in-depth discussion.The transparency of clinical research is an important guarantee for the standardization of research, the authenticity of results and the reliability of conclusions.This paper introduced the necessity of improving the transparency of RWS, and expounded the measures to promote the transparency of RWS from the aspects of protocol registration, statistical analysis plan publishing, data cleaning scheme formulation, result report specification and data sharing etc., so as to better control the confusion and bias, produce high-quality evidence that can be used for clinical decision-making, and reduce research waste.